NCT01646060已完成1 期
Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw
Zynex Monitoring Solutions2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Detect change in blood volume during blood draw
研究概览
简要总结
Zynex's blood volume monitor (BVM) is a non-invasive monitoring device to monitor blood volume and blood loss of a patient during surgery, post operatively and/or in recovery. This monitoring device will identify baseline blood volume and relative changes in blood volume using a specific algorithm to compare and review data already monitored during surgery, displaying blood volume and blood loss in real-time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Male, 18-65 years of age
- •Subject is suitable for a blood draw of a pint of blood
- •Weighs at least 110 pounds
排除标准
- •Subject has a heart condition that may interfere with the Zynex CM-1500
- •Subject has unstable or untreated heart disease
- •Subject has been diagnosed with chronic fatigue syndrome
- •Subject is taking coumadin (warfarin), heparin, or other prescription blood thinners for at least 7 days prior to blood draw
- •Subject donated blood within 8 weeks prior to blood draw
- •Subject has high or low blood pressure on the day of blood draw
- •Subject hemoglobin < 12.5 g/dL
结局指标
主要结局
Detect change in blood volume during blood draw
时间窗: 15-30 minutes
次要结局
- Detect insidious bleeding(15-30 minutes)
研究者
研究点 (2)
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